Castres, France, May 22, 2026
Pierre Fabre Laboratories has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has issued a positive opinion recommending approval of BRAFTOVI® (encorafenib) in combination with cetuximab and FOLFOX chemotherapy for the first-line treatment of adult patients with BRAFV600E-mutant metastatic colorectal cancer (mCRC). The recommendation marks a major advancement in targeted oncology treatment across Europe and could establish the therapy as the first and only BRAF-targeted combination regimen approved in the European Union for previously untreated BRAFV600E-mutant metastatic colorectal cancer patients.
The positive opinion is based on findings from the pivotal Phase 3 BREAKWATER trial, which demonstrated substantial clinical improvements in progression-free survival, objective response rate, and overall survival when compared with chemotherapy regimens with or without bevacizumab. The European Commission is expected to issue a final marketing authorization decision later this year.
BREAKWATER Trial Shows Strong Survival Benefits
According to the trial data, the combination of BRAFTOVI®, cetuximab, and mFOLFOX6 significantly improved progression-free survival compared with standard chemotherapy approaches. Patients receiving the targeted combination therapy achieved a median progression-free survival of 12.8 months, compared with 7.1 months for patients treated with chemotherapy with or without bevacizumab. The regimen also demonstrated a statistically significant improvement in objective response rates, confirming the strong anti-tumor activity of the targeted treatment approach.
Most notably, interim analysis results showed a major improvement in overall survival. Patients treated with the BRAFTOVI-based regimen achieved a median overall survival of 30.3 months, compared with 15.1 months for chemotherapy-treated patients, representing a 51% reduction in the risk of death. Researchers and oncology specialists described the findings as clinically meaningful for a patient population historically associated with aggressive disease progression and poor prognosis.
Advertisement
The safety profile observed during the study was generally consistent with the known safety characteristics of the individual therapies involved. Common treatment-related adverse events included nausea, anemia, diarrhea, vomiting, rash, and decreased appetite. Despite the occurrence of some grade 3 and 4 adverse events, investigators stated that the therapy’s overall benefit-risk profile remained favorable in the metastatic colorectal cancer setting.
Targeted Therapy Expands Precision Oncology in Europe
Metastatic colorectal cancer remains one of the most common and deadly cancers globally, with approximately 1.9 million new cases diagnosed worldwide in 2022. Within this population, BRAFV600E mutations occur in approximately 8% to 12% of metastatic colorectal cancer patients and are associated with significantly higher mortality risk compared with patients lacking the mutation.
Pierre Fabre Laboratories emphasized that the CHMP recommendation reinforces the growing importance of precision oncology and biomarker-driven treatment strategies in gastrointestinal cancers. The company stated that the therapy could provide physicians with a more personalized first-line treatment option capable of improving survival outcomes in a patient population with limited targeted treatment choices.
BRAFTOVI® is an orally administered kinase inhibitor specifically designed to target the BRAFV600E mutation, a key driver in multiple cancers including colorectal cancer, melanoma, and non-small cell lung cancer. The medicine is already approved in Europe for several BRAF-mutated cancers, including melanoma and previously treated metastatic colorectal cancer.
Pierre Fabre continues expanding its oncology portfolio through targeted therapies and international collaborations focused on areas with significant unmet medical need. The company reported that oncology generated approximately €565 million in revenue during 2025, highlighting the growing importance of cancer therapeutics within its global pharmaceutical strategy.
Industry experts believe the latest CHMP recommendation may strengthen the future adoption of targeted combination therapies in colorectal cancer while further accelerating precision medicine development across European oncology markets.
Source: Pierre Fabre press release
